Sterilization packaging is considered a medical device and thus it must undergo validation testing before being used in healthcare facilities. To ensure proper packaging that will maintain the integrity of sterilization, consult the packaging manufacturers’ instructions for use (IFU) and follow the sterilization standards and guidelines from the Association for…

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Editor's Note The Food and Drug Administration (FDA) on February 1 posted updated information on which manufacturers of automated endoscope reprocessors (AERs) for duodenoscopes have completed validation testing with adequate results. There are five companies in the US that manufacture AERs labeled to reprocess duodenoscopes. Companies that have completed their…

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Editor's Note Nearly 300 patients who had colonoscopies at Baystate Noble Hospital in Westfield, Massachusetts, may have been exposed to HIV and hepatitis because of a lack of adequate disinfection measures used to clean endoscopes, the January 23 Tech Times reports. The hospital started using new equipment that required a…

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Editor's Note The Food and Drug Administration (FDA) on January 21 issued final guidance for “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile." The document updates and clarifies information regarding sterilization processes and details about pyrogenicity the FDA recommends that sponsors include…

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Using best practices to sterilize surgical instruments can help lower infection rates and, in some cases, prevent death. Over the past few years, staff at Banner Boswell Medical Center in Sun City, Arizona, have worked to reduce immediate use steam sterilization (IUSS) rates. Thanks to improved communication and workflow between…

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Editor's Note Sterilized wrapped instrument trays demonstrated significantly greater protection than sterilized rigid containers against the ingress of airborne bacteria in this study. Of 111 rigid containers tested, 97 failed to maintain barrier performance, allowing bacterial ingress, while 0 of 161 wrapped trays had detectable contamination. Contamination rates of rigid…

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During the first half of 2015, the Joint Commission’s top “not compliant” survey citations stemmed from Infection Control IC.02.02.01, which relates to reducing the risk of infections associated with medical equipment, devices, and supplies. Surveyors cited critical access hospitals in 60% of the surveys, hospitals in 54%, and office-based surgery…

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Editor's Note The Food and Drug Administration (FDA) on November 13 ordered Custom Ultrasonics (Ivyland, Pennsylvania) to recall all of its automated endoscope reprocessors from healthcare facilities because of federal law violations and a consent decree entered with the company in 2007. The violations could result in an increased risk…

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Editor's Note The Food and Drug Administration (FDA) has identified bronchoscopes as a subset of devices that pose a greater likelihood of microbial transmission and represent a high risk of infection if not adequately reprocessed. The FDA is proactively investigating these devices to determine if additional reprocessing steps should be taken.…

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Editor's Note On September 11, the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) issued a health advisory recommending that healthcare facilities arrange for a professional to assess their reprocessing procedures for maintaining, cleaning, disinfecting, and sterilizing reusable medical devices. The agencies recommend that facilities…

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